Copper 64 PSMA I&T Meets Coprimary End Points of SOLAR Trial in Metastatic Prostate Cancer

Use of Copper 64 PSMA I&T for PET/CT imaging met the threshold for significance regarding region-level correct localization rate and patient-level correct detection rate in patients with histologically confirmed metastatic prostate cancer, meeting the coprimary end points of the phase 2 SOLAR trial.

Use of Copper 64 PSMA I&T for PET/CT imaging met the threshold for significance regarding region-level correct localization rate and patient-level correct detection rate in patients with histologically confirmed metastatic prostate cancer, meeting the coprimary end points of the phase 2 SOLAR trial (NCT05653856).1

The trial evaluated the safety, biodistribution, and image quality of the radiolabeled receptor-targeted diagnostic Copper Cu 64 PSMA I&T to identify metastatic prostate cancer using PET/CT imaging. The study was conducted in 26 patients with metastatic prostate cancer in the United States.

“The milestone announced today demonstrates Curium’s global commitment to driving innovations in prostate cancer diagnosis and treatment, and is extremely encouraging for prostate cancer patients,” Michael Patterson, chief executive officer of North America at Curium, said in a press release. “Our proven ability to reliably manufacture and distribute Cu-64 diagnostic agents throughout the United States means that we are well positioned for the upcoming phase 3 trials to ultimately improve the lives of patients.”

SOLAR is a prospective, open-label, phase 2 study evaluating copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.2

To be eligible for enrollment, patients at least 18 years of age must have histologically proven, recurrent prostate adenocarcinoma following curative-intent radical prostatectomy or radiation therapy, with at least 1 extraprostatic disease site suspected based on prior imaging or diagnosed by biopsy. Recurrent disease will be defined by a prostate-specific antigen (PSA) level above 0.2 ng/mL following prostatectomy, or 2-ng/mL rise in PSA over post–radiation treatment nadir.

In the trial, each patient will receive between a 7- and 9-mCi intravenous dose of copper Cu 64 PSMA I&T injection. All patients will undergo PET/CT imaging at 1 hour ± 15 minutes and 4 hours ± 30 minutes following copper Cu 64 PSMA I&T injection.

The PET/CT images will be read independently by 3 readers blinded to all patient information. Each reader will categorize images as disease or no disease based on tumor uptake of copper Cu 64 PSMA-I&T in each of the following 4 regions: prostate bed or prostate gland, lymph nodes (pelvic and extra pelvic), bone, and viscera/soft tissue. Interpretation of the reads will be used to determine the correct localization rate and cancer detection rate for 1 hour and 4-hour post-injection imaging of copper Cu 64 PSMA I&T PET/CT by comparison to the Composite Reference Standard.

“We are very pleased to report that our Copper Cu 64 PSMA I&T product for PET/CT imaging in the detection of recurrent prostate cancer has met the co-primary endpoints. Consistent with our mission to redefine the experience of cancer through our trusted legacy in nuclear medicine, we are encouraged by the readouts of the SOLAR phase 2 clinical trial,” Sakir Mutevelic, MD, MSc, chief medical officer at Curium, stated in the press release.1 “Our goal is to accelerate the Copper Cu 64 PSMA I&T phase 3 clinical development and move forward with pivotal phase 3 clinical trials in biochemical recurrence and initial staging setting in metastatic prostate cancer in early 2024.”

References

  1. Curium announces achievement of co-primary endpoints in phase 2 of its phase 1/2 SOLAR clinical trial imaging men with histologically-proven prostate cancer using copper Cu 64 PSMA I&T. News release. Curium. August 15, 2023. Accessed August 15, 2023. https://www.globenewswire.com/news-release/2023/08/15/2725665/0/en/Curium-Announces-Achievement-of-Co-Primary-Endpoints-in-Phase-2-of-Its-Phase-1-2-SOLAR-Clinical-Trial-Imaging-Men-With-Histologically-Proven-Prostate-Cancer-Using-Copper-Cu-64-PSMA.html
  2. Cu-64-PSMA-I&T positron emission tomography (PET) imaging of metastatic PSMA positive lesions in men with prostate cancer. ClinicalTrials.gov. Updated March 22, 2023. Accessed August 15, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05653856